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Hybrid medicines are defined as medicines that do not fill generic medicines' definition, forming a medicines group that stands half-way between reference medicinal products and generic medicines. The term "hybrid" was introduced in France in 2018, but the concept has existed for some fifteen years in Community legislation. The aim of this work is to expose hybrid medicines' legal framework, in Europe and in France. Hybrid medicines' European legal framework specifies in a guide of the European Medicines Agency, marketing authorization procedures that can be used for hybrid medicines, and what is required for marketing authorization applications. In France, a register of hybrid medicines' groups has been created, and registration procedures were specified in a decree at the end of 2019. Legal texts also underlined that substitution within hybrid medicines' group would be possible for some specific medical cases. Decrees specifying hybrid medicines' groups list and specific medical cases allowing substitution, are not appeared yet at the end of February 2021. Moreover, some elements have never been raised, particularly medical and economic assessment modalities.

Resume Objectifs L’objectif de ce travail est de dresser un etat des lieux des medicaments hybrides, terme introduit en France par la loi de financement de la securite sociale de 2019, en s’interessant particulierement a ceux references a l’Assistance Publique–Hopitaux de Paris (AP–HP), et d’analyser leurs enjeux therapeutiques et economiques. Methodes Des recherches par mots cles sur les sites internet d’instances europeennes et nationales ont permis d’etablir une liste des hybrides. L’analyse de leur profil et de leurs differences par rapport aux specialites princeps a ensuite ete effectuee. Une reflexion quant a leur assimilation a des « nouveaux medicaments » ou a des « generiques » a ete menee. Enfin, leurs interets, leurs risques et leurs couts ont ete evalues. Resultats En France 85 hybrides ont ete recenses, dont 41 commercialises et 21 admis a l’AP–HP. Six types de motifs de designation hybride ont ete identifies. Plus de 90 % des hybrides arrivent avec au moins un interet par rapport a leur specialite de reference, sans qu’il s’agisse forcement d’une innovation majeure. Cependant, plus d’un tiers presente un risque en cas de substitution. Les hybrides tendent a presenter des prix inferieurs aux princeps, avec neanmoins des decotes observees moins importantes que celles pratiquees pour les generiques. Conclusion Les hybrides constituent une population tres heterogene, en termes de differences par rapport aux princeps, d’interets et de risques. L’elaboration de regles communes a tous les hybrides est une tâche complexe et necessiterait de considerer les specificites de chaque couple hybride/princeps.

Resume La prise en charge pharmaco-therapeutique prend aujourd’hui de l’ampleur en etablissements publics de sante mentale (EPSM). Dans de telles structures ou les durees de sejours sont longues, le financement par dotation annuelle fait souvent obstacle a l’acces a l’innovation therapeutique. A l’aube du plan « Ma Sante 2022 », le risque de rupture du continuum de soin est bien present au regard de la complexite du financement de certaines therapies a haute valeur ajoutee. Malgre une volonte d’adaptation du systeme pour repondre aux besoins sanitaires en constante evolution, contrairement aux structures de soins de suite et de readaptation (SSR), aucune demarche relative aux medicaments onereux (MO) n’a ete entreprise a ce jour en EPSM a notre connaissance. Ceci renforce le decalage avec l’evolution de la recherche, et creuse davantage le fosse des inegalites entre secteurs sanitaires. Optimiser le financement des MO en psychiatrie octroierait la possibilite de diminuer l’etau des dotations en vigueur. A l’instar des reformes recentes en SSR, une prise en charge en sus des therapeutiques couteuses permettrait de reduire les arbitrages medicaux complexes : de la prevention a la reinsertion, la continuite de la prise en charge du patient en serait davantage garantie.

Since March 2019, émicizumab is indicated for the treatment of patients with severe haemophilia A without inhibitor. This therapy's price amounts approximately to €33 600 per 4 weeks for a 70kg patient which represents about two times more than a factor VIII concentrates treatment's price. This study aims to assess the budgetary impact for the French Health Insurance of an émicizumab therapy introduction for patients with severe haemophilia A without inhibitor. It was an observational, retrospective, and monocentric study. Every severe haemophilia A without inhibitor patient over 18 years old followed at the Cochin Hospital haemophilia treatment centre who received émicizumab from June 2020 and for at least one year have been included. The budgetary impact was estimated by comparing the total costs of patient care the year before versus the year after émicizumab initiation. Total costs of patient care included prices of i) treatments consumed, ii) consultations with specialist physicians, iii) hospitalizations and iv) imaging procedures. Thirty-eight patients were included. The total cost of patient care increased significantly the year after émicizumab introduction (P0.0001). On average, this cost was estimated at €537 887 ± €137 139 per patient whereas it was at €151 442 ± €94 708 the year before. While costs of physician consultations increased, no significant difference has been reported about hospitalizations and imaging costs. Over a one-year period, émicizumab therapy significantly increased the total costs of patient care. It is mostly caused by the drug price itself.

Contexte : Exercer la pharmacie en établissement de santé requiert des habiletés de gestion hospitalière et repose sur de bonnes connaissances acquises à l’université et par la pratique. Objectif : Comparer la formation théorique et l’exposition à la gestion pharmaceutique hospitalière (GPH) lors de l’internat en pharmacie hospitalière au Québec et en France. Méthodes : Il s’agit d’une étude descriptive et comparative. À partir des programmes académiques québécois (universités de Laval et de Montréal) et français (universités de Paris Descartes, Lille, Montpellier, Lyon), des outils pédagogiques ainsi que des textes normatifs, sept thématiques ont permis de définir la GPH et ont été utilisés comme variable de comparaison. Les résultats sont présentés dans trois tableaux distincts (profils comparés de la formation théorique, des expositions en GPH et des sept thématiques de la formation théorique et de l’exposition à la GPH) et ont été recueillis auprès d’un panel d’étudiants composé de quatre internes français dans le cadre d’échanges avec des résidents québécois. Aucune analyse statistique n’a été utilisée. Résultats : Académiquement, un programme de GPH obligatoire existe au Québec dirigé par un intervenant. En France, le programme de GPH est divisé en différentes notions abordées dans plusieurs enseignements obligatoires ou facultatifs menés par divers intervenants. Au sein des établissements de santé, les internes français ont plus d’opportunités d’exposition à la GPH que les québécois en raison de la durée de l’internat, de la diversité des stages (polyvalence) et de l’autonomie attendue. Conclusion : L’enseignement et l’exposition à la GPH diffèrent entre le Québec et la France et les approches sont complémentaires.

Hybrid medicines are defined as medicines that do not fill generic medicines' definition, forming a medicines group that stands half-way between reference medicinal products and generic medicines. The term "hybrid" was introduced in France in 2018, but the concept has existed for some fifteen years in Community legislation. The aim of this work is to expose hybrid medicines' legal framework, in Europe and in France. Hybrid medicines' European legal framework specifies in a guide of the European Medicines Agency, marketing authorization procedures that can be used for hybrid medicines, and what is required for marketing authorization applications. In France, a register of hybrid medicines' groups has been created, and registration procedures were specified in a decree at the end of 2019. Legal texts also underlined that substitution within hybrid medicines' group would be possible for some specific medical cases. Decrees specifying hybrid medicines' groups list and specific medical cases allowing substitution, are not appeared yet at the end of February 2021. Moreover, some elements have never been raised, particularly medical and economic assessment modalities.

The aim of this study is to give an overview of hybrid medicines, term introduced in France by the Social Security Financing Act for 2019, with special attention to those available in Paris Public Hospitals (AP-HP), and to analyze their therapeutic values and economic issues.Research by keywords on European and French health authorities' websites was done to provide a list of hybrid medicines. Then, an analysis of their profile and of their differences from reference medicinal products was done. A reflection on hybrid medicines likeness to "new medicines" or to "generic medicines" was carried out. Lastly, their therapeutic interests, their risks and their costs were assessed.In France 85 hybrid medicines were identified, including 41 commercialized, and 21 available in AP-HP. Six different types of differences from the reference medicinal product were found out. Over 90% of hybrid medicines show at least one interest compared to the reference medicines, even if it is not a major innovation. However, more than a third of hybrid medicines are associated to a risk in case of drug substitution with the reference medicinal product. Hybrid medicines costs appear to be lower than reference medicines, but with smaller discounts than what is usually observed with generic medicines.Hybrid medicines constitute a very heterogeneous population, whether in terms of differences from reference medicines, of interests or risks. Common rules development for all hybrid medicines may be complex and would require taking every couple hybrid/reference medicines specificities into account.

The worsening pharmaceutical products shortage required the central purchasing structure of AP-HP to include a new criterion on supply safety in the tenders' procedures. Each provider answering to the tender needs to complete a dedicated form. The aim is to review the collected information and assess its relevance.This study is based on a retrospective analysis conducted on the last 2 tenders' procedures forms (one started in September 2019 and the other in February 2020).These 2 tenders' procedures were composed of 155 lots. The form response rate was 81,4%. The average rating on 20 was 10,9±3,8. The rates could be very variable depending on the lots. Regarding the 2020s tenders procedures, 57.8% of specialties were classified as drugs of major therapeutic interest. A shortage management plan exists for 24.0% of them. Providers indicated several sources of raw materials (36,1%) and several factories (35,5%). The average advanced stock was 4.1±3.8 months in France and 2.3±2.6 months in Europe. The information system implemented by suppliers scored an average of 15 out of 20.This study allowed us to know better the suppliers' organisation. The concerning points are the low stocks and the discrepancies in the suppliers' drugs of major therapeutic interest classification of a same product and the existence of a shortage management plan. This form will be maintained with more specific questions. An assessment will be done to determine the relevance of this form to prevent disruptions.

Background and importance In order to ensure the sustainability of the French healthcare system, the government launched two incentives to increase biosimilar use in August 2018, within the framework of the social security funding law. The first redirected 20% of the price difference between the reference product and its biosimilar to the hospital, for every biosimilar prescription from the hospital, and provided it in retail pharmacies. The second (called article 51) was an experiment where 40 hospitals were selected after a call for a proposal. The clinical units of these 40 hospitals received 30% of the price difference between the reference product and its biosimilar for every biosimilar prescription from the hospital. Aim and objectives The aim of this study was to compare the efficacy of both incentives 10 months after implementation in October 2018. Material and methods IQVIA Xponent data were used to evaluate public hospital prescriptions of etanercept. These are based on 14 000 retail pharmacy panels (60% of the French retail pharmacies) and allows observation of the number of boxes delivered in retail pharmacies linked to the initial hospital prescription. Data from the 40 hospitals selected in the experiment were compared with hospitals not in the experiment. We assessed savings that could be made if the experiment was extended to every hospital after 10 months Results In July 2019, the average use of etanercept biosimilar reached 44.2% (+19.5 points compared with October 2018) in the 40 hospitals selected in the experiment whereas it increased by 10.5 points in the other hospitals. After 10 months of the experiment, there was a difference of 12.3 points between the groups. The government expected to reach a difference of 15 points to prove the efficacy of this measure after 3 years. The 40 selected hospitals represent about 46% of potential etanercept prescriptions. If all hospitals reach 44.2% biosimilar use, the savings could be doubled, from 650k€ to 1.4M€. Conclusion and relevance The first results of this experiment show that incentives to prescribe etanercept biosimilars seem to have an impact on biosimilar use in France. References and/or acknowledgements Acknowledgements to Iqvia and Biogen France. Conflict of interest Corporate sponsored research or other substantive relationships: Iqvia and Biogen France.

Resume Objectifs L’hemophilie est une maladie hemorragique rare. Elle se traduit cliniquement par des hemorragies spontanees ou provoquees. Les facteurs antihemophiliques constituent le principal traitement. Ce sont cependant des medicaments tres onereux. Les objectifs de cette etude etaient de determiner le cout de ces traitements en hospitalisation ainsi que les facteurs l’influencant. Methode Une etude retrospective monocentrique a ete menee sur les patients atteints d’hemophilie congenitale hospitalises a l’hopital Cochin entre le 1er janvier 2014 et le 31 decembre 2015 et ayant recu au moins une injection de facteur antihemophilique pendant leur hospitalisation. Un recueil des donnees cliniques et des traitements recus pendant l’hospitalisation a ete realise pour chaque patient. Resultats Cinquante et un patients ont ete inclus dans l’etude avec un total de 68 hospitalisations. Le cout median des facteurs antihemophiliques par hospitalisation etait de 16 908 €. La part mediane des facteurs anthemophiliques sur le cout total de l’hospitalisation etait de 68,2 %. Le cout des facteurs par sejour etait plus eleve pour les hemophiles severes (p = 0,015) et pour les chirurgies majeures (p Conclusions Les facteurs antihemophiliques representent la part la plus important du cout d’hospitalisation d’un hemophile. Leur cout en hospitalisation varie en fonction de nombreux facteurs et est susceptible d’evoluer avec l’arrivee des facteurs antihemophiliques a longue duree d’action.

L’hospitalisation a domicile (HAD) doit faire face a la une demande croissante de la population d’etre soignee a domicile et a un engagement des pouvoirs publics pour favoriser son developpement. Un des freins identifies pour sa croissance est son systeme de financement qui devrait etre revise en 2018. Le financement des medicaments couteux est au cœur des preoccupations actuelles. Cette etude menee sur les anticancereux par voie orale (AKVO) a l’HAD AP-HP en 2014 a pour objectif de determiner si leurs couts sont trop eleves par rapport aux tarifs des sejours respectifs. Apres identification des patients ayant eu des AKVO a l’HAD AP-HP en 2014, les donnees tarifaires de leurs sejours sont extraites avec le departement d’information medicale, afin de calculer, pour chaque sejour, le ratio cout du traitement/cout du sejour. Sur l’annee 2014, pour l’HAD de l’AP-HP, les sejours ou le cout du traitement represente 30 % et plus du forfait hospitalier sont estimes a 17 % (42 sejours sur 241). Neanmoins, le ratio peut depasser 100 % pour quelques sejours (n=6). Ces resultats illustrent les difficultes de financement de certaines specialites pharmaceutiques dans les forfaits d’HAD. La constitution d’une liste en sus specifique a l’HAD peut etre une solution pour atteindre l’objectif de doublement de l’activite de l’HAD fixe par le Ministere de la Sante.